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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K193285
Device Name V-ONESTEP
Applicant
Vitromed GmbH
Hans-Knöll-Str 6
Jena,  DE 07745
Applicant Contact Deepesh Changat
Correspondent
Regulatory Specialists, Inc.
628 El Mirador Dr.
Fullerton,  CA  92835
Correspondent Contact Robyn Scopis
Regulation Number884.6180
Classification Product Code
MQL  
Date Received11/27/2019
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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